-
- News
- Books
Featured Books
- smt007 Magazine
Latest Issues
Current IssueBox Build
One trend is to add box build and final assembly to your product offering. In this issue, we explore the opportunities and risks of adding system assembly to your service portfolio.
IPC APEX EXPO 2024 Pre-show
This month’s issue devotes its pages to a comprehensive preview of the IPC APEX EXPO 2024 event. Whether your role is technical or business, if you're new-to-the-industry or seasoned veteran, you'll find value throughout this program.
Boost Your Sales
Every part of your business can be evaluated as a process, including your sales funnel. Optimizing your selling process requires a coordinated effort between marketing and sales. In this issue, industry experts in marketing and sales offer their best advice on how to boost your sales efforts.
- Articles
- Columns
Search Console
- Links
- Events
||| MENU - smt007 Magazine
Digicom Electronics Upgrades Medical Device Quality Certification to ISO 13485:2016
November 27, 2018 | Digicom ElectronicsEstimated reading time: 2 minutes
Digicom Electronics, Inc. has upgraded its medical quality device certification to ISO 13485:2016. The ISO 13485 standard is a series of requirements that help device makers develop a quality management system to ensure the quality, safety, and effectiveness of the medical devices they manufacture. Digicom specializes in complex products and those that require the utmost precision, reliability, durability, and enhanced performance.
Digicom's Diamond Track Process helps medical device companies with their complete process, from design for manufacturing to fully integrated box build systems. Digicom handles both small runs and high-volume manufacturing and produces the prototype, sources the components, manufactures and tests the product, assists with process validation, and ships the product directly to its end user.
To eliminate device failure from PCB contamination, Digicom uses a proprietary process to clean circuit boards. It removes ion contamination to below detectable levels and results in PCBs that far exceed IPC-TM-650 cleanliness standards. Digicom also manufactures its own nitrogen and pipes it to its manual, reflow, and selective soldering processes to help strengthen the bonds and improve adhesion in the soldering process.
"Manufacturers of medical devices must seek every way possible to eliminate failures of those devices," explained Mo Ohady, general manager of Digicom Electronics. "Many major failures result from a weakness in the solder joint that connects the wire bond to the printed circuit board, the solder that connects the device or package to the board, or board contamination. That's why we spent years developing our cleaning process and implementing a nitrogen system. Using nitrogen is not an absolute requirement; however, among other things, nitrogen can help to strengthen the bond and improve solder adhesion in the soldering process."
Digicom experts will be available at the BIOMEDevice Show, San Jose, CA, on December 5 and 6, in booth 433, to discuss your electronic manufacturing and assembly needs.
Digicom is a certified small business and HUBZone with AS9100:2016 (Rev D) aerospace, ISO 9001:2015, ISO 13485:2016 medical devices quality, quality system regulation 21 CFR 820, and ITAR certifications.
About Digicom Electronics
Digicom Electronics offers advanced electronics manufacturing with "Made in the USA" quality that fits the needs of larger enterprises while at the same time providing the benefits and individual attention needed to serve start-up companies. Digicom collaborates in all aspects of the process from the design for manufacturability to the final, fully compliant product. Material procurement and management services include planning, purchasing, expediting, and warehousing of components and materials. Digicom has been manufacturing in the California Bay Area since 1982. It is a certified small business and HUBZone with AS9100:2016 (Rev D) aerospace, ISO 9001:2015, ISO 13485:2016 medical devices quality, quality system regulation 21 CFR 820, and ITAR certifications.
Suggested Items
AIM to Highlight NC259FPA Ultrafine No Clean Solder Paste at SMTA Wisconsin Expo & Tech Forum
04/18/2024 | AIMAIM Solder, a leading global manufacturer of solder assembly materials for the electronics industry, is pleased to announce its participation in the upcoming SMTA Wisconsin Expo & Tech Forum taking place on May 7 at the Four Points by Sheraton | Milwaukee Airport, in Milwaukee, Wisconsin.
Hentec/RPS Publishes an Essential Guide to Selective Soldering Processing Tech Paper
04/17/2024 | Hentec Industries/RPS AutomationHentec Industries/RPS Automation, a leading manufacturer of selective soldering, lead tinning and solderability test equipment, announces that it has published a technical paper describing the critical process parameters that need to be optimized to ensure optimal results and guarantee the utmost in end-product quality.
Empowering Electronics Assembly: Introducing ALPHA Innolot MXE Alloy
04/16/2024 | MacDermid Alpha Electronics SolutionsIn the rapidly evolving electronics industry, where innovation drives progress, MacDermid Alpha Electronics Solutions is committed to setting a new standard. Today, we are pleased to introduce ALPHA Innolot MXE, a revolutionary alloy meticulously engineered to address the critical needs of enhanced reliability and performance in modern electronic assemblies.
New Book on Low-temperature Soldering Now Available
04/17/2024 | I-Connect007I-Connect007 is pleased to announce that The Printed Circuit Assembler’s Guide to… Low-temperature Soldering, Vol. 2, by subject matter experts at MacDermid Alpha Electronics Solutions, is now available for download.
Inkjet Solder Mask ‘Has Arrived’
04/10/2024 | Pete Starkey, I-Connect007I was delighted to be invited to attend an interactive webinar entitled “Solder Mask Coating Made Easy with Additive Manufacturing,” hosted by SUSS MicroTec Netherlands in Eindhoven. The webinar was introduced and moderated by André Bodegom, managing director at Adeon Technologies, and the speakers were Mariana Van Dam, senior product manager PCB imaging solutions at AGFA in Belgium; Ashley Steers, sales manager at Electra Polymers in the UK; and Dr. Luca Gautero, product manager at SUSS MicroTec Netherlands.